Home / Recalls / Cordis US Corp / Z-0286-2024

Z-0286-2024 Class I Ongoing

Recalled by Cordis US Corp — Miami Lakes, FL

Recall Details

Product Type
Devices
Report Date
November 15, 2023
Initiation Date
September 26, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
30 devices

Product Description

Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter

Reason for Recall

Non-sterile product labeled as sterile was distributed.

Distribution Pattern

US Distribution to: OK

Code Information

UDI/DI 10705032025935, Lot Number 18223410

Other recalls by Cordis US Corp

  • Z-1510-2025 Class II — Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, (March 4, 2025)
  • Z-1511-2025 Class II — Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, (March 4, 2025)
  • Z-1330-2025 Class II — Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guid (February 7, 2025)
  • Z-0675-2024 Class II — MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral (November 28, 2023)
  • Z-0674-2024 Class II — MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral art (November 28, 2023)
  • Z-1485-2023 Class I — ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC (March 24, 2023)
  • Z-1492-2023 Class I — ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE (March 24, 2023)
  • Z-1484-2023 Class I — ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC (March 24, 2023)
  • Z-1487-2023 Class I — ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC (March 24, 2023)
  • Z-1493-2023 Class I — ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE (March 24, 2023)